GUEST COLUMNISTS

• Maybe Biosimilar Applicants Should Dance After All

  The decision to engage in the BPCIA patent dance with a reference product sponsor is rarely black and white. Early dismissals in cases like Eagle v. Slayback and Amgen v. Coherus are just one factor a biosimilar applicant should consider.

• A Brief History Of Parenteral Process Validation — How We Got Here

  Process validation has been at the center of attention of regulators and parenteral industry practitioners for years — more than 40 years to be exact. This article will look at how process validation evolved to become the primary means of ensuring consistent, high-quality production of parenterals.

• Are We Adequately Assessing U.S. Pharma Supply Chain Risks?

  There are gaps in our country’s collective knowledge required to determine the severity of the current pandemic’s risk to our supply chain for drugs. Undoubtedly, these gaps will remain, leaving questions that need to be answered and will, hopefully, serve as a road map for legislators and advocates of the industry.

• Key Engineering & Facility Considerations For Liposome Manufacturing

  This, the second installment in a series, covers factors in installing a liposome manufacturing process in a facility and the engineering points to consider in doing so.

• Brazil’s Medical Device Market: Patient Demographics, Healthcare System, And Outlook

  Government initiatives, favorable demographic conditions, and increased patient purchasing power are among the factors that make Brazil an attractive medtech investment definition. Challenges are weighed against opportunities in this article, the second of a two-part series examining the Brazilian medtech market and factors that affect it.

• Healing From A Pandemic And Building Resilience Into Future Clinical Trials

  We must now rethink our design strategies and planning processes before starting studies to find the right fit-for-purpose virtual solutions and push the boundaries on our designs to ensure we are collecting what is truly important for research and our patients.

• Old Drug, New Tricks: Will The BPCIA Drive Generic Competition For Insulins?

  High demand, few suppliers, and soaring prices point to the need for more generic competition in the insulin market. This article discusses recent changes to the legal and regulatory framework governing insulin approval that might facilitate such entry.

• A Novel Medtech Strategic Framework For Post-COVID-19

  As healthcare systems begin again to expand beyond emergency and urgent cases, pent-up demand will exist for elective procedures. But, which procedures will take priority?